DevelRx

About DevelRx

DevelRx is a R&D-based consultancy organisation providing strategic and scientific support on the discovery, safety, toxicity and regulatory approval of molecules that enter the central nervous system (CNS), ranging from traditional CNS drug candidates to psychedelics and cannabinoids and peripherally-acting agents that may penetrate the brain. The Leadership Team at DevelRx is composed of senior professionals with over 30 years of experience of the pharmaceutical industry and exemplary academic credentials. Our consultants have proven track-records in drug discovery, global drug development and registration with key roles in regulatory submissions in the USA (FDA; Food and Drug Administration), UK (MHRA; Medicines and Healthcare products Regulatory Agency), Europe (EMA; European Medicines Agency), Canada and Japan. DevelRx’s experts have provided key pre-clinical support for 16 new drug registrations in the therapeutic indications of attention deficit hyperactivity disorder, binge-eating disorder, epilepsy, schizophrenia, Parkinson’s disease, obesity, migraine, opiate withdrawal and opiate-induced constipation. Our areas of expertise include the pharmacology of drugs of abuse. We are globally acknowledged experts on assessing abuse potential of new drugs and have performed abuse/dependence evaluations for more than 50 clients. We design abuse testing experiments tailored to the unique pharmacological profile of each new drug, supervise safety testing and prepare the regulatory submission. Our services include robust, quantitative and reproducible chemical similarity assessment of new compounds to drugs with known or likely abuse potential including Tanimoto analysis (with Scitegrity) and 8-factor analyses of abuse potential. Our expertise and advice has enabled our clients to achieve optimal drug scheduling for their compounds. We also offer abuse potential assessment waiver submissions. Further information on our services can be found on our website.

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